PlainRecalls
FDA Devices Moderate Class II Terminated

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

Reported: September 5, 2012 Initiated: August 10, 2012 #Z-2284-2012

Product Description

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

Reason for Recall

STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

Details

Recalling Firm
Steris Corporation
Units Affected
64 units
Distribution
Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.. Recalled by Steris Corporation. Units affected: 64 units.
Why was this product recalled?
STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Which agency issued this recall?
This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2284-2012.